FDA again rejects use of ecstasy as a treatment for post-traumatic stress disorder

The Food and Drug Administration (FDA) rejected for the third time a new drug that includes midomafetamine (MDMA, also known as ecstasy) as a form of treatment for post-traumatic stress disorder (PTSD). The agency requested further studies and evidence of the drug's efficacy.

The drug was developed by pharmaceutical company Lykos Therapeutics. The company said in a release that it will "pursue all available regulatory pathways to expeditiously bring a potential new treatment to the 13 million Americans who live with PTSD."

"Lykos will work diligently in the coming months to address FDA's concerns and to take advantage of agency processes to resolve scientific disagreements. Following the FDA meeting, Lykos expects to provide an update on next steps for the resubmission," the statement said.

Also, the company responded to the FDA's request and called it "deeply disappointing." Amy Emerson, CEO commented, "The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades. ... While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature."

MDMA was investigated considerably for use in the treatment of post-traumatic stress disorder. However, there are currently no MDMA treatments available for medical use in the country.